NCT06203483

Brief Summary

Knee arthroplasty surgery numbers are increasing depending on joint deformities and cartilage degenerations. Severe postoperative pain may occur in these patients due to surgery and the placed prosthesis. The aim of study is to compare the effectiveness of AKB and PENG block for postoperative analgesia management after knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 3, 2024

Last Update Submit

March 26, 2026

Conditions

Keywords

Total Knee ArthroplastyPostoperative Analgesia ManagementAdductor Canal BlockPerıcapsular Nerve Group Block

Outcome Measures

Primary Outcomes (1)

  • Global recovery scoring system (patient satisfaction scale)

    The investigators will use the Turkish version of Quality of Recovery / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

    The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

Secondary Outcomes (2)

  • Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

    Patients will be evaluated at the first 24 hours period postoperatively.

  • The use of rescue analgesia

    Meperidine consumption will be recorded at the first 24 hours period postoperatively.

Study Arms (2)

Adductor canal block

ACTIVE COMPARATOR

Adductor canal block will be performed at the end of the surgery. Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.

Drug: Adductor canal block

PENG block

ACTIVE COMPARATOR

PENG Block will be performed at the end of the surgery. Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.

Drug: PENG block

Interventions

A linear ultrasound probe will be placed medial to the patella, the probe will be advanced to cephalad, and the superficial femoral artery will be visualized. The block site will be confirmed by injecting 5 ml of saline around the saphenous nerve in the subsartorial region under ultrasound guidance. Then, 30 ml of local anesthetic solution containing 0.25% bupivacaine (Marcain 0.5% AstraZeneca, England) will be administered.

Adductor canal block

The probe will be placed at the anterior superior level of spina iliaca, parallel to the inguinal ligament. The probe will be scanned gradually towards the caudal. After the anterior inferior of the spina iliaca is visible, the probe will be slightly turned medially until the hyperechoic shadow of the superior pubic ramus is visible. The psoas muscle tendon will be visualized above the superior pubic ramus, then 5 ml of saline will be injected under the psoas tendon and the block location will be confirmed. After that 30 ml of 0.25% bupivacaine will be administered.

PENG block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for total knee arthroplasty under spinal anesthesia

You may not qualify if:

  • history of bleeding diathesis
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedur

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mürsel Ekinci

Bursa, Turkey (Türkiye)

Location

Related Publications (5)

  • Kim S, Bosque J, Meehan JP, Jamali A, Marder R. Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006. J Bone Joint Surg Am. 2011 Jun 1;93(11):994-1000. doi: 10.2106/JBJS.I.01618.

    PMID: 21531866BACKGROUND
  • Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.

    PMID: 27627711BACKGROUND
  • Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.

    PMID: 22335278BACKGROUND
  • Sahoo RK, Jadon A, Sharma SK, Nair AS. Pericapsular nerve group (PENG) block for hip fractures: Another weapon in the armamentarium of anesthesiologists. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):295-296. doi: 10.4103/joacp.JOACP_295_20. Epub 2021 Jul 15. No abstract available.

    PMID: 34349384BACKGROUND
  • Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

    PMID: 19916251BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two models for this study. Adductor canal block group, and pericapsular nerve group block group
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

January 20, 2024

Primary Completion

March 10, 2024

Study Completion

June 10, 2024

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The investigators will not share IPD

Locations